QPS Consultant GLP Quality Risk Management

Janssen Pharmaceutica is recruiting for a consultant to support Preclinical Quality Risk Management with a focus on GLP.

This position will help enable end-to-end quality risk management for Janssen R&D business partners performing or outsourcing GLP work to promote submission success and protect approval status. The role includes proactive risk identification, assessment, and mitigation at the level of external service providers, internal GLP-related processes or programs in close collaboration with business partner functions such as within Bioresearch quality and compliance, Nonclinical Safety, Discovery Sciences, Janssen Biotherapeutics, Plant and Material Protection, Ecotoxicology, Viral Vaccines, Environmental Health and Safety.

Job Title: QPS Consultant GLP Quality Risk Management

Location: Belgium, Worldwide responsibilities (100% remote)

Working hours: 40/week

The contract is until 31/12/2021 (high chances for extension!!)

All EU countries welcomed to apply!

Must be EU Citizen

• Position requires a minimum of 5 relevant experience (working with GLP minimum 8)

-English language

Key Responsibilities:

• Support the management and execution of the GLP internal and external Service Provider (ESP) integrated quality risk management framework in collaboration with key Janssen and ESP stakeholders.

Key responsibilities include support for:

1.              Maintenance of GLP universe (internal and ESP) across Janssen R&D.

2.              Identification of systemic risks related to GLP quality management systems (internal and ESP) and/or Janssen’s oversight processes with input from different angles including Health Authority information, performance monitoring, audit findings, business partner strategies and insights, evolving regulatory requirements, and trends, etc.

3.              Collaboration with cross-functional preclinical development teams to assess identified risks and develop risk mitigation activities.

4.              Ensuring appropriate risk monitoring, oversight, and communication.

5.              Capturing key risks and mitigation plans in a risk management system and assure all actions are driven to resolution

• Support development of the master audit schedule and scoping of GLP audits as requested from BRQC QA
• Help address quality components related to the qualification of GLP ESPs in support of the overall sourcing strategy
• Contextualize key quality insights to primary stakeholders and provide quality consultancy
• Support timely management of significant-quality events related to internal and ESP contractual services in collaboration with relevant preclinical functional teams including but not limited to formal escalation, support of CAPA development, and/or overseeing execution of risk management activities
• Provide quality input into governance models led by key GLP stakeholders to assure operational management is assessed for potential quality impact. Facilitate risk mitigation activities as needed to address quality concerns that arise from operational governance models
• Support ESP components of integration plans following a license or acquisition deal

Qualifications

Education:

BA/BS required MA/MBA preferred

Experience and Skills:

Required:

• Active expertise in GLP (min 8 years)
• In-depth knowledge of global OECD and FDA GLP regulations and guidelines
• Familiar with different GLP study types and components such as toxicology, pathology, bioanalysis, genetic toxicology, toxicokinetics in a global multisite setting.
• Basic knowledge of GMP
• Collaborative and open attitude, customer-oriented, diplomatic and problem-solving skills, familiar with risk-based thinking.

Other:

Risk management experience is preferred.

Must be proficient in the English language

Must be proficient with common computer system applications (Sharepoint, Word, Excel, Powerpoint)

Awareness of quality requirements in Discovery and non-GLP development, GCLP, and Animal Welfare is preferred.

In return, you will receive the opportunity for a long-term contract (minimum 12 months), a very competitive hourly rate & a chance to work with one of the world’s leaders in the Pharmaceutical industry, Johnson & Johnson.

If you think this role could be for you then please apply directly today!